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About the Role

The Patient Centered Solutions (PCS) team leads the industry in measuring the patient experience by combining strategic consulting with scientific knowledge to design and execute research that incorporates the patient voice into new medicine development and commercialization.

Responsibilities

Serve as the subject matter expert for COA endpoint strategy, development, regulatory strategy, and instrument science in client engagement and project delivery.
Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning.
Bring COA expertise into client meetings, workshops, and strategic discussions.
Differentiate proposals and client solutions through expert-driven COA strategy narratives.
Translate emerging scientific and regulatory expectations into actionable client recommendations.
Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions.
Support preparation for and participation in FDA meetings as the COA subject matter expert.
Guide sponsors on evidence expectations, context of use, and fit-for-purpose COA strategies.
Provide scientific leadership in the development of new COA instruments from concept to validation-ready tools.
Lead and advise on drafting and refinement of COA instrument items, response options, recall periods, and scoring approaches.
Oversee qualitative research activities supporting content validity, including concept elicitation and cognitive interviewing.
Ensure new COA instruments are patient-centered, scientifically robust, and fit-for-purpose for clinical and regulatory use.
Serve as subject matter expert overseeing internal project teams executing COA strategy and development work.
Review and approve key scientific deliverables to ensure quality, rigor, and alignment with best practices.
Mentor and coach COA consultants, supporting capability development across the organization.
Support business development through proposal leadership, solution design, and client presentations.
Contribute to the evolution of COA strategy methodologies, frameworks, and reusable assets.
Maintain a strong external profile through publications, conference presentations, and scientific collaborations.
Represent IQVIA as a recognized expert in COA science and endpoint strategy.
Contribute to academic teaching, advisory boards, or industry working groups where appropriate.

Requirements

Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their application in clinical research.
Extensive experience developing COA endpoint strategies across multiple therapeutic areas.
Hands-on experience developing new COA instruments, including item writing and qualitative validation.
Experience supporting FDA-facing endpoint strategy and regulatory interactions.
Ability to mentor junior team members.
Excellent scientific writing, presentation, and stakeholder engagement skills.
Strong publication record and recognized credibility in outcomes research or COA measurement science.
Well-developed written and verbal communication skills including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing.
An entrepreneurial nature and interest in developing new client offerings and solutions and in building the capability to deliver the same.

Skills

COA endpoint strategy
COA endpoint development
COA regulatory strategy
COA instrument science
Client engagement
Project delivery
Measurement science
Scientific writing
Presentation skills
Stakeholder engagement
Outcomes research
COA measurement science
Business development
Proposal leadership
Solution design
Client presentations
Methodology development
Framework development
External scientific leadership
Publications
Conference presentations
Scientific collaborations
Academic teaching
Advisory boards
Industry working groups

Experience Level

Associate Principal/ Principal

Education Level

Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred.

About the Company

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Equal Opportunity

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.